Keyword

ePRO for Phase III and Beyond

Supporting Risk Evaluation and Mitigation Strategy (REMS) Submissions

By ensuring the quality of post-marketing data, Almac’s ePRO solutions assist manufacturers in complying with the Food and Drug Administration Amendments Act (2007). Almac’s ePRO technology forms an integral part of a sponsor’s REMS strategy, providing an accurate and cost-effective solution for conducting large and lengthy studies, which by design encourages patients to remain engaged with your study. The data collected by Almac’s ePRO solutions when combined with the clinical data from healthcare providers, creates a 360-degree view of the patient outcome at baseline, as well as during and after therapy. This complete therapy view provides valuable information on the trial experience, including hard-to-quantify data such as the physical and emotional impact of symptoms and the toxicity of therapies.

Disease Management and Medication Compliance

Almac’s ePRO solutions are used to support post-marketing pharmacovigilance programs, forming a vital part of any sponsor company’s overall risk management strategy. Almac’s ePRO solutions:

Manage the capture of additional data from large patient populations about the long-term safety of new products in real-world settings.

Facilitate the reporting of adverse events and other safety concerns, ensuring that a product’s benefit-to-risk profile remains acceptable.

Support healthcare providers – and those who pay for healthcare – by collecting clinical evidence that new therapies provide better outcomes or greater value than existing products on the market

Data Collection for Regulatory Drug Approvals

By working with Almac, sponsors benefit from the strong foundations that our ePRO solutions are built upon. ePRO from Almac combines:

Scientific, clinical, and regulatory expertise ensuring the best solution is delivered to support your regulatory submission